Camrelizumab Combined With AVD in the First-line Treatment for Patients With Advanced Classical Hodgkin's Lymphoma

Classical Hodgkin Lymphoma Clinical Trial

Official title:

Phase II Clinical Trial of Camrelizumab Combined With AVD (Epirubicin, Vincristine and Dacarbazine) in the First-line Treatment for Patients With Advanced Classical Hodgkin's Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04067037
• Other study ID #: HNSZLYY01
• Status: Recruiting
• Phase: Phase 2
• Start date: August 26, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Henan Cancer Hospital
• Contact: Yanyan Liu, M.D. Ph.D
• Phone: +8613818176375
• Email: yyliu[@]zzu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective phase II clinical trial to observe the efficacy and safety of Camrelizumab combined with AVD in the first-line treatment for patients with advanced classical Hodgkin's lymphoma.

Description:

Hodgkin's lymphoma (HL) is a kind of malignant tumor of the lymph system, approximately 95% of which are classical hodgkin's lymphoma (cHL). Currently, ABVD and BEACOPP are commonly used in the first-line treatment for cHL. There are about one third of patients, whose pre-treatment assessment are mainly advanced cHL, suffering relapse and drug resistance. PD-1/PD-L1 signaling pathway plays an important role in the development and progression of cHL. Nivolumab and Pembrolizumab have been used in the therapy in relapsed and refractory patients with cHL. Camrelizumab, a humanized anti-PD-1 IgG4 monoclonal antibody, is independently developed in China. The goal of our trial is to assess the efficacy and safety of Camrelizumab combined with AVD (Epirubicin, Vincristine and Dacarbazine) in the first-line treatment for patients with advanced classical Hodgkin's lymphoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age between 18 to 75 years old (including 18 and 75)

2. Diagnosed as advanced classical hodgkin's lymphoma based on histopathology

3. Subjects must be untreated (Ann Arbor Stage III/IV or Ann Arbor II with B symptoms along with mediastinal big tumor or extranodal changes)

4. No receiving chemotherapy before enrollment

5. Having at least one measurable lesions

6. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2

7. Life expectancy no less than 3 months

8. enough main organ function

9. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study

10. Agreeing to sign the written informed consents

Exclusion Criteria:

1. Diagnosed as nodular lymphocyte predominant lymphoma or grey-zone lymphoma

2. Diagnosed as central nervous system lymphoma

3. usage of immunosuppressants before enrollment and the dose of immunosuppressant used >10mg / day oral prednisone for more than 2 weeks

4. Previously treated with anti-PD-1/PD-L1/PD-L2/CTLA-4

5. Active autoimmune disease

6. Vaccination with anti-tumor vaccine or other immune treatments less than 3 months

7. Serious surgery and trauma less than two weeks

8. Other malignant tumor history or active malignant tumor need be treated

9. Systemic therapy for serious acute/chronic infection

10. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months

11. Active tuberculosis

12. Vaccination with live attenuated vaccine less than 4 weeks

13. HIV-positive, AIDS patients and untreated active hepatitis

14. Researchers determine unsuited to participate in this trial

Related Conditions & MeSH terms

• Classical Hodgkin Lymphoma
• Hodgkin Disease
• Lymphoma

Intervention

Drug:
• Camrelizumab
30mg, Intravenous administration on day 1 and day 15 of each 4-week cycle until disease progression or unacceptable toxicity develops, up to 6 cycles.
• Epirubicin
35mg/m2, Intravenous administration on day 1 and day 15 of each 4-week cycle until disease progression or unacceptable toxicity develops, up to 6 cycles.
• Vincristine
1.4mg/m2, Intravenous administration on day 1 and day 15 of each 4-week cycle until disease progression or unacceptable toxicity develops, up to 6 cycles.
• Dacarbazine
375mg/m2, Intravenous administration on day 1 and day 15 of each 4-week cycle until disease progression or unacceptable toxicity develops, up to 6 cycles.

Locations

Country	Name	City	State
China	Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate	the total proportion of patients with complete response (CR) and partial response (PR)	every 8 weeks from the day of the first cycle of treatment to 1 year after last patient's enrollment (each cycle is 28 days)
Secondary	2-year progression-free survival	the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurrs first	from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first, up to 2 years after last patient's enrollment (each cycle is 28 days)
Secondary	overall survival	from date of first day of treatment to the date of death by any cause	from date of the first cycle of treatment to the date of death from any cause, assessed up to 5 years (each cycle is 28 days)
Secondary	incidence and relationship with study drugs of grade 3-4 adverse events and abnormal laboratory examinations	the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03) and abnormal laboratory examinations	from the date of the first cycle of treatment to 1 year after last patient's enrollment (each cycle is 28 days)